NCT05910476

Brief Summary

the investigators would like to compare the differences between roschvastin and atovastatin in patients who require high-dose statin/ejetimib to undergo a new generation of drug elution stent implantation for cardiovascular disease and maintain LDL cholesterol below 55 mg/dL.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Timeline
4mo left

Started May 2023

Typical duration for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
May 2023Sep 2026

First Submitted

Initial submission to the registry

March 31, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

May 3, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2026

Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

3.4 years

First QC Date

March 31, 2023

Last Update Submit

November 20, 2025

Conditions

Coronary Artery DiseaseDyslipidemias

Outcome Measures

Primary Outcomes (2)

  • Percentage of statins changed

    Percentage of statins changed to discontinuation or intolerance (muscle pain, muscle efficiency, elevated liver level, etc.) within a year

    12 months

  • Rate at which LDL cholesterol remains below 55 mg/dL

    Rate at which LDL cholesterol remains below 55 mg/dL in all 1-year blood tests

    12 months

Secondary Outcomes (12)

  • The rate at which LDL cholesterol is maintained at 55 mg/dL in the blood test after a month

    1 months

  • Cardiovascular death

    12 months

  • number of non-fatal myocardial infarction

    12 months

  • number of non-fatal stroke

    12 months

  • number of coronary artery re-perfusion

    12 months

  • +7 more secondary outcomes

Study Arms (2)

rosuvastatin/ezetimibe 20/10mg

ACTIVE COMPARATOR

rosuzet 10/20mg

Drug: a high dose of statin/ezetimib

atorvastatin/ezetimibe 40/10mg

ACTIVE COMPARATOR

NB zet 10/40mg

Drug: a high dose of statin/ezetimib

Interventions

a high dose of statin/ezetimibDRUG

In randomization, 100 patients will proceed with Rosuvastatin/Ezetimib 20/10 mg and 100 patients will proceed with Atovastatin/Ezetimib 40/10 mg. A new generation of drug elution stents can be inserted and later registered, and if the patient agrees to participate in the study, they are randomly assigned after stent implantation.

atorvastatin/ezetimibe 40/10mgrosuvastatin/ezetimibe 20/10mg

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Patients who underwent a new generation of drug elution stent implantation for cardiovascular disease

You may not qualify if:

  • LDL cholesterol levels below 55 mg/dL without statin treatment
  • Serum AST/ALT with an acute liver disease within a month or a normal upper limit that is not continuously explained
  • Allergies or overreactions to statins
  • Estimated Dawn of Less than 1 Year
  • If it is determined that follow-up is not possible for more than one year
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yongin Severance Hospital

Yongin, Gyeonggi-do, 16995, South Korea

Location

MeSH Terms

Conditions

Coronary Artery DiseaseDyslipidemias

Interventions

Hydroxymethylglutaryl-CoA Reductase InhibitorsEzetimibe

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Anticholesteremic AgentsHypolipidemic AgentsAntimetabolitesMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesEnzyme InhibitorsLipid Regulating AgentsTherapeutic UsesAzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Yongcheol Kim, MD

    Yonsei University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 31, 2023

First Posted

June 18, 2023

Study Start

May 3, 2023

Primary Completion (Estimated)

September 22, 2026

Study Completion (Estimated)

September 22, 2026

Last Updated

November 25, 2025

Record last verified: 2025-11

Locations

KR(1)